United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2002_register
executive
2010-09-23
article
Amendment of Regulations on Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
Proposed Rules
D09002ee1bded6499
D09002ee1bded6525
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) proposes to amend its regulations to change the labeling requirements concerning aluminum in small volume parenterals (SVPs) and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN). FDA proposes that the immediate container labels of SVPs and PBPs containing 25 micrograms per liter (mcg/L) or less of aluminum may state: ``Contains no more than 25 mcg/L of aluminum'' instead of stating the exact amount of aluminum they contain. FDA is taking this action in response to a request from industry.
67 FR 52429
https://www.govinfo.gov/app/details/FR-2002-08-12/02-20300
02-20300
fr12au02-19
4160-01-S
Docket No. 02N-0241
https://www.govinfo.gov/app/details/FR-2002-08-12/02-20300
https://www.govinfo.gov/content/pkg/FR-2002-08-12/html/02-20300.htm
https://www.govinfo.gov/content/pkg/FR-2002-08-12/pdf/02-20300.pdf
3 p.
52429
52431
67 FR 52429
Code of Federal Regulations
Title 21 Part 201
21 CFR Part 201
Amendment of Regulations on Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition; Federal Register Vol. 67, Issue
PRORULE
02-20300
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2002-10-28
Docket No. 02N-0241
4160-01-S
02-20300
Proposed rule.
The Food and Drug Administration (FDA) proposes to amend its regulations to change the labeling requirements concerning aluminum in small volume parenterals (SVPs) and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN). FDA proposes that the immediate container labels of SVPs and PBPs containing 25 micrograms per liter (mcg/L) or less of aluminum may state: ``Contains no more than 25 mcg/L of aluminum'' instead of stating the exact amount of aluminum they contain. FDA is taking this action in response to a request from industry.
Submit written or electronic comments by October 28, 2002.
Christine F. Rogers, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
Human drugs:
Total parenteral nutrition; aluminum use in large and small volume parenterals; labeling requirements,
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 67, no. 155
Office of the Federal Register, National Archives and Records Administration
2002-08-12
continuing
daily
deposited
born digital
223 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2002-08-12
P0b002ee1809be8c2
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr12au02
https://www.govinfo.gov/app/details/FR-2002-08-12
https://www.govinfo.gov/content/pkg/FR-2002-08-12/pdf/FR-2002-08-12.pdf
https://www.govinfo.gov/content/pkg/FR-2002-08-12/xml/FR-2002-08-12.xml
fdlp
52383
52593
DGPO
2010-09-23
2023-05-04
FR-2002-08-12
machine generated
eng
FR
FR-2002-08-12
67
155